DH responds to media reports on sale of COVID-19 oral drugs at drugstores

     In response to media enquiries on reports on the sale of COVID-19 oral drugs at drugstores, a spokesman for the Department of Health (DH) said today (December 30) that two types of COVID-19 oral drugs (Paxlovid and Molnupiravir), which are currently supplied in Hong Kong by two drug manufacturers, namely Pfizer Corporation Hong Kong Limited and Merck Sharp & Dohme (Asia) Ltd, have been registered as pharmaceutical products in Hong Kong in accordance with the Pharmacy and Poisons Regulations (Cap. 138A). At present, only the two above-mentioned pharmaceutical products are approved by the Pharmacy and Poisons Board of Hong Kong (the Board) as registered oral drugs for COVID-19 treatment.
     The spokesman stressed that currently the two COVID-19 oral drugs could only be supplied to healthcare institutions and doctors in public and private sectors. Patients could only be prescribed the relevant drugs by registered medical practitioners when needed, and drug retail outlets cannot procure the relevant oral drugs from suppliers nor sell them to the public. Having considered factors such as patient's suitability, relevant contraindications and possible side effects of using the two registered COVID-19 oral drugs, the Board has thus imposed the above special restriction to the registration conditions.
     The spokesman reiterated that the two COVID-19 oral antiviral drugs belong to Part 1 Third Schedule poisons under the Pharmacy and Poisons Ordinance (the Ordinance), i.e. prescription only medicines. Illegally possession and sale of Part 1 Third Schedule poisons without a doctor's prescription, and illegal possession and sale of unregistered pharmaceutical products are criminal offences. The maximum penalty for each offence, once convicted, is a fine of $100,000 and two years' imprisonment.
     The DH has mechanism in place to monitor the sale of pharmaceutical products in the market, and will collect intelligence through various channels. In light of the relevant media reports, the DH has proactively looked into the situation and stepped up regulatory measures and inspections. In general, when suspected illegal sale or possession of unregistered pharmaceutical products is detected, the DH will immediately carry out investigations and conduct joint operations with other law enforcement agencies where necessary, and any irregularities so found will be dealt with in accordance with the laws. The DH and other law enforcement agencies will continue to strengthen inspections and enforcement actions to safeguard public health.
     The spokesman strongly urged members of the public not to buy or use products of doubtful composition or from unknown sources. The safety, quality and efficacy of unregistered pharmaceutical products are not guaranteed.
     According to the Ordinance, pharmaceutical products must satisfy the criteria of safety, efficacy and quality for registration with the Board before they can be sold or supplied in Hong Kong. Upon submission of application and the relevant documentation required from applicants of registration, the Board will evaluate the registration application in accordance with established procedures and requirements. The Board can also impose conditions when approving the registration. All registered pharmaceutical products should carry a Hong Kong registration number on the package in the format of "HK-XXXXX". But the Ordinance allows the import of unregistered pharmaceutical product to be possessed or used for the purpose of treatment of a particular patient or conduct clinical trials by a registered medical practitioner. The Ordinance also stipulates that only holders of valid wholesale dealer licence issued by the Board may carry on business as an importer/exporter of pharmaceutical products.

Ends/Friday, December 30, 2022
Issued at HKT 19:30